Back to resultsThe Evaluation of Ankle Joint Braces Efficiency
Primary Purpose
Ankle Injuries, Ankle Sprains
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ankle joint brace 1
ankle joint brace 2
ankle joint brace 3
ankle joint brace 4
ankle joint brace 5
Sponsored by
About this trial
This is an interventional basic science trial for Ankle Injuries focused on measuring ankle joint brace, atfl, oxford foot model
Eligibility Criteria
Inclusion Criteria:
- age 18-35
- female or male
- good health condition
- chronic ankle joint instability (for chronic ankle instability group)
Exclusion Criteria:
- lower limb injuries (last 6 months)
- extreme sports athletes
- no chronic ankle joint instability (for chronic ankle instability group)
Sites / Locations
- Józef Piłsudski University of Physical Education in Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
young healthy adults
young adults with chronic ankle joint instability
Arm Description
Gait measured by Vicon Nexus System
Gait measured by Vicon Nexus System
Outcomes
Primary Outcome Measures
Oxford Foot Model Angles
Ankle angles, Hindfoot Tibia angles and Forefoot Hindfoot angles caculated by Oxford Foot Model, colected with the use of Vicon Motion Capture system
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04586036
Brief Title
The Evaluation of Ankle Joint Braces Efficiency
Official Title
The Evaluation of Ankle Joint Braces Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barbara Łysoń
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury. Authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Ankle Sprains
Keywords
ankle joint brace, atfl, oxford foot model
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
young healthy adults
Arm Type
Experimental
Arm Description
Gait measured by Vicon Nexus System
Arm Title
young adults with chronic ankle joint instability
Arm Type
Experimental
Arm Description
Gait measured by Vicon Nexus System
Intervention Type
Other
Intervention Name(s)
ankle joint brace 1
Intervention Description
The influence of ankle joint brace 1 on gait biomechanics
Intervention Type
Other
Intervention Name(s)
ankle joint brace 2
Intervention Description
The influence of ankle joint brace 2 on gait biomechanics
Intervention Type
Other
Intervention Name(s)
ankle joint brace 3
Intervention Description
The influence of ankle joint brace 3 on gait biomechanics
Intervention Type
Other
Intervention Name(s)
ankle joint brace 4
Intervention Description
The influence of ankle joint brace 4 on gait biomechanics
Intervention Type
Other
Intervention Name(s)
ankle joint brace 5
Intervention Description
The influence of ankle joint brace 5 on gait biomechanics
Primary Outcome Measure Information:
Title
Oxford Foot Model Angles
Description
Ankle angles, Hindfoot Tibia angles and Forefoot Hindfoot angles caculated by Oxford Foot Model, colected with the use of Vicon Motion Capture system
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-35
female or male
good health condition
chronic ankle joint instability (for chronic ankle instability group)
Exclusion Criteria:
lower limb injuries (last 6 months)
extreme sports athletes
no chronic ankle joint instability (for chronic ankle instability group)
Facility Information:
Facility Name
Józef Piłsudski University of Physical Education in Warsaw
City
Warsaw
State/Province
Mazowsze
ZIP/Postal Code
00-968
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of Ankle Joint Braces Efficiency
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